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CTRI Number  CTRI/2022/03/041156 [Registered on: 16/03/2022] Trial Registered Prospectively
Last Modified On: 19/03/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Study the efficacy of vatsakadi gana vati with chandraprabha vati in pcod induced obese patients  
Scientific Title of Study   Comparative clinical study of efficacy of Vatsakadi gana Vati with Chandraprabha vati in Sthaulya (Obesity) associated by PCOD  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shital Shamarav Patil  
Designation  PhD Scholar  
Affiliation  DR DYPATIL COLLEGE OF AYURVED AND RESEARCH CENTRE 
Address  DEPARTMENT OF SAMHITA AND SIDDHANT HON SHREE ANNASAHEB DANGE AYURVED MEDICAL COLLEGE AND RESEARCH CENTER ASHTA
DEPARTMENT OF aYURVED SAMHITA AND SIDDHANT DR D.Y. PAATIL AYURVED COLLEGE PIMPRI PUNE-18
Pune
MAHARASHTRA
416301
India 
Phone  9673860067  
Fax    
Email  shtl.patil3@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DRMrudula Joshi 
Designation  PROFESSOR  
Affiliation  DR D Y PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE 
Address  Dr D.Y.Patil college of Ayurved and research centre Pimpri Pune 18
dr shital s patil, hon shree Annasaheb dange ayurved medical college ashta
Pune
MAHARASHTRA
415311
India 
Phone  09673860067  
Fax    
Email  mrudula.doctor@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Shital Shamarav Patil  
Designation  PhD Scholar  
Affiliation  DR D Y PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE 
Address  Dr D.Y.Patil college of Ayurved and research centre Pimpri Pune 18
hon shree annasaheb dange ayurved medical college ashta
Pune
MAHARASHTRA
415311
India 
Phone  09673860067  
Fax    
Email  shtl.patil3@gmail.com  
 
Source of Monetary or Material Support  
DR. D. Y. PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE, PIMPRI, PUNE-18 
Hon shree Annasaheb Dange Ayurved Medical college Ashta 
 
Primary Sponsor  
Name  DR D Y PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE 
Address  DR. D. Y. PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE, PIMPRI, PUNE-18 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
Hon shree Annasaheb Dange Ayurved Medical college Ashta  Hon Shree Annasheb Dange Ayurved medical college Ashta 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mrudula Joshi   Dr D Y Patil College Of Ayurved and Research center   Dr D Y Patil College Of Ayurved and Research center Pune kayachikitsa and strirog OPD
Pune
MAHARASHTRA 		 9226279270

mrudula.doctor@gmail.com 
Dr Shital Shamarav Patil  Hon Shree Annasaheb Dange Ayurved Medical College Ashta  Hon Shree Annasaheb Dange Ayurved Medical College kayachikitsa and strirog OPD
Sangli
MAHARASHTRA 		 09673860067

shtl.patil3@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
DR. D. Y. PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE  Approved 
Hon shree Annasaheb Dange Ayurved medical College and research center Ashta   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E668||Other obesity. Ayurveda Condition: STHAULYA (OBESITY) ASSOCIATED BY PCOD, (2) ICD-10 Condition:E668||Other obesity. Ayurveda Condition: STHAULYA (OBESITY) ASSOCIATED BY PCOD,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Vastakadi Gana Vati , Reference: Ashtang hruday sutra 15/33,34, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 2000(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 24 Weeks, anupAna/sahapAna: Yes(details: ushnodak), Additional Information: Sthaulya is caused due to vitiation of Kapha dosha and Medo, Mamsa dhatu. So the treatment should require which stabilize these vitiated dushyas. Vastakadi Gana is selected for treatment as in benefits of it given that it cures Vata, Kapha, and Meda. The 23 drugs given under this Vatsakadi Gana are Katu, Tikta rasatmak, Katu vipaki, ushna viryatmak, which are responsible to karsh
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1 Patients having BMI 25 and above
2 Patients diagnosed with PCOD
 
 
ExclusionCriteria 
Details  1 Obesity with other complications like thyroid disorder, coronary heart disease etc
2 Uterine prolapse, cervical prolapse, fibroids or any other pelvic disease
3 Pregnant women and lactating mothers
4 Any anal diseases
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
changes in
1. Body Mass Index: BMI
2. Measurement of circumference: - Body Girth Measurement.
3. Polycystic ovary: USG
4. Lipid profile before and after.
5. BSL before and after.
6. Hormonal assess –LH FSH, Testosterone, Estrogens, prolactin
 		 24 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
There is significant difference in effectiveness of Vatsakadi Gana Vati and
Chandraprabha Vati on Sthaulya (obesity) with PCOD in women
 		 24 weeks  
 
Target Sample Size   Total Sample Size="102"
Sample Size from India="102" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial
Modification(s)  		 Phase 2 
Date of First Enrollment (India)   30/03/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [shit.patil3@gmail.com].

  6. For how long will this data be available start date provided 20-05-2021 and end date provided 20-12-2027?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - no
Brief Summary  

Does Vatsakadigana Vati is the effective Ayurvedic solution to Sthaulya (Obesity) With PCOD in women of age group 20 to 40 years & to compare the efficacy with Chandraprabha Vati because both obesity and PCOD leading to anovulation.Since its description in 1935 by Stein and Leventhal, much has been learned about the pathophysiology of PCOS from its neuroendocrine involvement to the link between obesity, insulin resistance (IR) and PCOS. Typically, PCOS manifests as hyperandrogenemia, obesity, polycystic ovaries and chronic anovulation.

 
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